Chairperson’s Opening Address

Protecting The Pharmaceutical Supply Chain: Is RFID The Silver Bullet?

Aaron Graham Vice President & Chief Security Officer Purdue Pharma

• Examining how counterfeit, adulterated and misbranded drugs penetrate legitimate channels of distribution
• Looking at how the World Wide Web is exploited to perpetuate this heinous crime against public health
• Considering evolving technologies and how they can address this serious threat to patient safety 

Case Study: California Jet Stream to ePedigree Compliance

	Kamal Mustafa President Secure Symbology
	A Catalent Pharma Solutions Representative
	An Alien Technologies Representative

• Manufacturing challenges presented by the new California epedigree law
• Ensuring implementation to meet the January 1, 2009 deadline
• Achieving unit level serialization of prescription drugs to prevent counterfeit medications
• Developing a cost-effective, reliable solution for all types of pharmaceutical packaging
• Examining the ROI aspects of an e-pedigree compliance serialization
• A CPM (Critical Path Method) analysis of a complete serialization and ePedigree installation

Reviewing Updates On Legislation And Regulation Of The US Drug Supply Chain

	Donna S. Wall, PharmD, Rph, BCPS, FASHP Board Member, Critical Care Clinical Pharmacist Indiana State Board of Pharmacy, Indiana University Hospital
	Steve Able Assistant Dean For Clinical Programs School of Pharmacy and Pharmaceutical Sciences, Purdue University

• Updating new and confusing regulations
• Discussing the regulation of reverse distributors
• Examining the problems encountered with “common carriers”
• Looking at VAWD and it’s effect on the industry

Successful Regulatory Affairs Practices To Ensure Full Comprehension Of Pedigree Regulations

Brian Jude Loiacono Senior Regulatory Specialist Henry Schein

• Staying up-to-date with state and federal pedigree legislation as changes and new mandates continue to arise
• Building stronger relationships with key governmental agencies to ensure a continuing understanding of pedigree regulations
• Developing and maintaining a successful department that will help your organization achieve pedigree compliance

Paul J.Maloney Member Carr Maloney P.C.

• Scope of Problem
• The Impact of Counterfeit Drugs on The Manufacturer, Distributor, and Dispenser
• Survey of Representative Cases
• Future Shock or Business as Usual—A Look Into the Pedigree Crystal Ball

Reviewing The Most Recent Updates From The CA. Board Of Pharmacy

Judith Nurse Supervising Inspector California State Board of Pharmacy

• Reviewing the latest updates directly from the board
• Examining a timeline for enactment and compliance
• Maintaining awareness of possible changes and key information you need to know as the deadline approaches

Examining The Impact Of Amphetamine & Methamphetamine Precursor Diversion And Why It Affects The Pharmaceutical Industry

Philippa LeVine Special Agent Office Of Enforcement Operation Dangerous Drugs And Chemicals Section, Drug Enforcement Administration

• Looking at methamphetamine and its impact on society
• Evaluating current trends in amphetamine & methamphetamine precursor diversion
• Reviewing the impact on the pharmaceutical industry

BEST PRACTICES IDEA XCHANGE   

Champagne Round Table
Actively take part in six group discussions on significant subject matters that impact your business strategies and operational goals.  Sit down with your peers and channel partners and draw best practices that you can directly apply when you get back to the office!

Topic #1: Looking At Government Relations Issues Facing Distributors
Moderator: Andrew Van Ostrand, Vice President, Policy and Research, Health Industry Distributors Association (HIDA)

Topic #2: Examining Issues Surrounding RFID Pilot Programs
Moderator:  William McLaury, Executive Director, US Supply Chain Management, Novartis Pharmaceuticals Corporation

Topic #3: Analyzing Federal And State Pedigree Compliance
Moderator:  Ron Lanton III J.D., Pharmaceutical Industry Analyst, HD Smith

Topic #4: How To Authenticate A Pedigree
Moderator: Sam Karsch, Chief Executive Officer, Med Search

Topic #5: Exploring Future Industry Trends

Chairperson’s Opening Address

Examining The Safe And Secure Pharmaceutical Supply Chain Management Challenges

Leonardo DeCandia Senior Vice President, Supply Chain Management AmerisourceBergen

• Reviewing trading partner trust and collaborative practices
• Ensuring the safe flow of products, funds and information
• Examining internal manufacturer and internal distributor challenges
• Optimizing the value chain with a focus on patient safety

Mastering Pedigree Compliance In A Complex Federal And State Environment

	Ron Lanton Pharmaceutical Industry Analyst HD Smith
	Brian Jude Loiacono Senior Regulatory Specialist Henry Schein

• Examining the FDA’s regulatory role and it’s effect on the industry
• Reviewing the PDMA and the impact on state government policy making
• Looking at different state models and the problems that arise from decentralization

Comprehending California Pedigree And The Burden Of The Manufacturer

Andrew Harrison Senior Manager, Global Regulatory Affairs Baxter Healthcare Corporation

• Gaining an in-depth perspective of California's pedigree legislation
• Learning how California’s pedigree rule affects the supply chain and the burden of the manufacturer
• Managing through ambiguity in the rule and other interpretive issues
• Looking at strategy development ideas for supply chain compliance programs

Understanding End User Issues And How They Affect The Safety Of The Entire Supply Chain

	Donna S. Wall, PharmD, Rph, BCPS, FASHP Board Member, Critical Care Clinical Pharmacist Indiana State Board of Pharmacy, Indiana University Hospital
	Steve Abel Assistant Dean For Clinical Programs, School of Pharmacy and Pharmaceutical Sciences, Purdue University

• Discussing the convoluted distribution of drugs from manufacturer to bedside
• Examining identified errors and ways they can be prevented
• Learning new ways the industry can partner with their end users to create a safer system

The Internationalization Of Prescription Medicine Counterfeiting

Peter Pitts President, Center for Medicine In The Public Interest (CMPI) Senior Vice President, Global Health Affairs, Manning Selvage & Lee Former Associate Commissioner, FDA

• Examining the growth in counterfeiting
• Looking at why free trade is an opportunity for criminals
• Reviewing what is being done to address the problem

Panel Discussion: Outlining Federal And State Pedigree Requirements To Gain A Clear Picture Of What Is Necessary To Comply

In-Depth Workshops

Participate in one of two in-depth, classroom-style workshops, presented by subject matter experts in the field. Gain a comprehensive understanding of the subject at hand, and participate in an interactive activity to solidify learnings.

Sign up to attend either Workshop A or B.

Participate in an engaging dialogue lead by our speaker faculty.  Clarify any confusing subject matters, ask questions and bring up issues you didn’t get the opportunity to mention in the earlier sessions.